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Design

The PLATFORM (Prospective LongitudinAl Trial of FFR
CT: Outcome and Resource IMpacts) trial was designed to assess whether patients with suspected
coronary artery disease (CAD) evaluated using a HeartFlow-guided strategy would undergo fewer invasive
coronary angiograms that showed no significant CAD as compared to patients evaluated based on standard
practice.

Patients all had suspected CAD (pre-test likelihood of 20-80%) and presented in two groups based
on the intended evaluation plan before enrollment: planned invasive coronary angiogram and planned
non-invasive test.

Half of PLATFORM patients underwent usual care and half were evaluated using a HeartFlow-guided
strategy. Additional care decisions were made by the sites and were not dictated by the protocol.

Enrollment

584 patients were enrolled at 11 centers in Europe.

Results

For patients with a planned invasive angiogram, a HeartFlow-guided strategy:

Reducing the Cost of Care

Provides Significant Savings to the Healthcare System
2

A HeartFlow-guided strategy
reduced the overall costs to the healthcare system by more than $4,000 per patient after one year.
The mean one-year per-patient cost for the usual care strategy was $12,145 compared to the $8,127 cost
for the HeartFlow-guided strategy. When including the $1,500 cost of the HeartFlow Analysis, the cost
reduction is 26 percent.

Learn more about the PLATFORM trial

Design

The PLATFORM (Prospective LongitudinAl Trial of FFR
CT: Outcome and Resource IMpacts) trial was designed to assess whether patients with suspected
coronary artery disease (CAD) evaluated using a HeartFlow-guided strategy would undergo fewer invasive
coronary angiograms that showed no significant CAD as compared to patients evaluated based on standard
practice.

Patients all had suspected CAD (pre-test likelihood of 20-80%) and presented in two groups based
on the intended evaluation plan before enrollment: planned invasive coronary angiogram and planned
non-invasive test.

Half of PLATFORM patients underwent usual care and half were evaluated using a HeartFlow-guided
strategy. Additional care decisions were made by the sites and were not dictated by the protocol.

Enrollment

584 patients were enrolled at 11 centers in Europe.

Results

For patients with a planned invasive angiogram, a HeartFlow-guided strategy:

Improving Patient Quality of Life

Provides a Better Patient Experience
3

Patients in the HeartFlow-guided arm of the PLATFORM trial experienced an improvement in quality of life
from baseline to 90-day follow-up.

Among patients with a planned non-invasive test, improvements in quality of life were greater for patients
undergoing a HeartFlow-guided strategy than patients undergoing usual care.

Learn more about the PLATFORM trial

Design

The PLATFORM (Prospective LongitudinAl Trial of FFR
CT: Outcome and Resource IMpacts) trial was designed to assess whether patients with suspected
coronary artery disease (CAD) evaluated using a HeartFlow-guided strategy would undergo fewer invasive
coronary angiograms that showed no significant CAD as compared to patients evaluated based on standard
practice.

Patients all had suspected CAD (pre-test likelihood of 20-80%) and presented in two groups based
on the intended evaluation plan before enrollment: planned invasive coronary angiogram and planned
non-invasive test.

Half of PLATFORM patients underwent usual care and half were evaluated using a HeartFlow-guided
strategy. Additional care decisions were made by the sites and were not dictated by the protocol.

Enrollment

584 patients were enrolled at 11 centers in Europe.

Results

For patients with a planned invasive angiogram, a HeartFlow-guided strategy:

Conclusion

Incorporating a HeartFlow-guided strategy may change the course of treatment for patients with suspected
coronary artery disease.

Source: Curzen, et al. EuroPCR 2015.

PROMISE FFR
CT Study

PROMISE FFR
CT is a sub-study of the PROMISE (PROspective Multicenter Imaging Study for Evaluation of
chest pain) trial and provides insight into how the HeartFlow Analysis can effectively serve as
a frontline test for patients with suspected coronary artery disease (CAD).

PROMISE FFR
CT demonstrates the effectiveness of a HeartFlow-guided strategy:

Fewer patients would have undergone an unnecessary invasive angiogram.
*

A HeartFlow-guided strategy may have reduced unnecessary angiograms by almost 80%, compared to
functional testing (11% vs. 52%).

Many patients would have had their invasive angiogram deferred.

Nearly 30% of invasive angiograms would have been avoided if a HeartFlow-guided strategy had
been available. This may have reduced the rate of invasive angiograms in the anatomical testing
(CT) arm of PROMISE from 12.1% to 8.8% (compared to the rate of 8.1% measured in the functional
testing arm).

Patients who would have had an invasive angiogram deferred would have had a very low adverse event
rate.

Of the patients whose angiogram would have been deferred based on a HeartFlow-guided strategy,
only two had events. Both patients had no CAD on invasive angiography and would not have been
identified in either frontline diagnostic strategy.

Patients in need of revascularization (e.g., stent or coronary artery bypass graft) would have
been effectively identified.

Over 90% of patients who underwent a revascularization were identified by the HeartFlow Analysis
as having significant CAD.

The HeartFlow Analysis is Built on a
FOUNDATION OF CLINICAL RESEARCH

In prospective, multicenter clinical studies enrolling more than 600 patients, the HeartFlow Analysis demonstrated
high diagnostic accuracy in the diagnosis of coronary artery disease.

Using invasive FFR as the reference standard

What is FFR?

What is FFR?

Fractional Flow Reserve (FFR) is the most accurate and reliable measure for determining a lesion’s
impact on blood flow to the heart and is now considered to be the standard of care for guiding
percutaneous coronary revascularization in guidelines by the European Society of Cardiology
8 and the American College of Cardiology.
9

FFR is measured at the time of invasive coronary angiography. A pressure sensing wire is introduced
into the coronary arteries, medications are introduced to simulate maximal coronary blood flow
and then the wire directly measures pressure before and after a coronary stenosis. This data is
used to determine the FFR value which can help a clinician to understand whether a coronary lesion
is obstructing blood flow to a patient’s heart.

What is FFR
CT?

FFR
CT is a non-invasive method to provide clinicians with information on whether or not a coronary
lesion is obstructing blood flow without the need to perform an invasive FFR measurement. Using
a standard CT scan of the heart and physiologic simulations of blood flow, the HeartFlow FFR
CT Analysis mathematically assesses how a coronary artery narrowing may be impacting blood
flow to the heart.